"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
(en joo ve-e)
(synthetic conjugated estrogens, B) Tablets
Read this PATIENT INFORMATION before you start taking ENJUVIA, and each time you refill your ENJUVIA prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
What is the most important information I should know about ENJUVUA (an estrogen mixture)?
- Using estrogen-alone may increase your chance of getting
cancer of the uterus (womb).
Report any unusual vaginal bleeding right away while you are taking ENJUVIA. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
- Using estrogen-alone may increase your chances of getting strokes or blood clots.
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia.
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- You and your healthcare provider should talk regularly about whether you still need treatment with ENJUVIA.
What is ENJUVIA?
ENJUVIA is a prescription medicine that contains a mixture of estrogen hormones.
What is ENJUVIA used for?
ENJUVIA is used after menopause to:
- reduce moderate or severe hot flashes
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause”.
When estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe.
- treat moderate to severe vaginal dryness and pain with
sex, due to menopause
You and your healthcare provider should talk regularly about whether you still need treatment with ENJUVIA to control these problems. If you use ENJUVIA only to treat your vaginal dryness, or pain with sex, talk with your healthcare provider about whether a topical vaginal product would be better for you.
Who should not take ENJUVIA?
Do not take ENJUVIA if you:
- have unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- currently have or have had certain cancers
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take ENJUVIA.
- had a stroke or heart attack
- currently have or have had blood clots
- currently have or have had liver problems
- have been diagnosed with a bleeding disorder
- are allergic to ENJUVIA or any of its ingredients See the list of ingredients in ENJUVIA at the end of this leaflet.
- think you may be pregnant
ENJUVIA is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take ENJUVIA if the test is positive and talk to your healthcare provider.
What should I tell my healthcare provider before I take ENJUVIA?
Before you take ENJUVIA, tell your healthcare provider if you:
- have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any vaginal bleeding to find out the cause.
- have any other medical conditions
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, angioedema (swelling of the face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop taking ENJUVIA.
- are breastfeeding
The hormones in ENJUVIA can pass into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how ENJUVIA works. ENJUVIA may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take ENJUVIA?
- Take ENJUVIA exactly as your healthcare provider tells you to take it.
- Take one ENJUVIA tablet by mouth at the same time each day.
- If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.
- Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with ENJUVIA.
- ENJUVIA may be taken with or without food.
What are the possible side effects of ENJUVIA?
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- heart attack
- blood clots
- breast cancer
- cancer of the lining of the uterus (womb)
- cancer of the ovary
- high blood pressure
- high blood sugar
- gallbladder disease
- liver problems
- changes in your thyroid hormone levels
- enlargement of benign tumors of the uterus (“fibroids”)
Call your healthcare provider right away if you get any of the following warning signs, or any other unusual symptoms that concern you:
- new breast lumps
- unusual vaginal bleeding
- changes in vision or speech
- sudden new severe headaches
- severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue
Less serious, but common side effects include:
- breast tenderness or pain
- irregular vaginal bleeding or spotting
- stomach or abdominal cramps, bloating
- nausea and vomiting
- hair loss
- fluid retention
- vaginal yeast infection
These are not all the possible side effects of ENJUVIA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or does not go away.
You may report side effects to Teva Pharmaceuticals at 1-888-483-8279 or to FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with ENJUVIA?
- Talk with your healthcare provider regularly about whether you should continue taking ENJUVIA.
- If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
- See your healthcare provider right away if you get vaginal bleeding while taking ENJUVIA.
- Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in
the blood), diabetes, are overweight, or if you use tobacco, you may have a
higher chance of getting heart disease.
Ask your healthcare provider for ways to lower your chance of getting heart disease.
How should I store ENJUVIA?
- Store ENJUVIA at room temperature between 59®F to 86®F (15®C to 30®C).
Keep ENJUVIA and all other medicines out of the reach of children.
General information about safe and effective use of ENJUVIA.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take ENJUVIA for conditions for which it was not prescribed. Do not give ENJUVIA to other people, even if they have the same symptoms you have. It may harm them.
This leaflet provides a summary of the most important information about ENJUVIA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ENJUVIA that is written for healthcare professionals.
You may also obtain further information by calling the toll free number 1-888-4838279.
What are the ingredients in ENJUVIA?
Active Ingredient: synthetic conjugated estrogens, B.
Inactive Ingredients: ascorbyl palmitate, butylated hydroxyanisole, colloidal silicon dioxide, edetate disodium dehydrate, plasticized ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, purified water, iron oxide red, titanium dioxide, polyethylene glycol, polysorbate 80, triacetate and triacetin/glycerol. In addition, the
- 0.45 mg tablets contain iron oxide black and iron oxide yellow;
- 0.9 mg tablets also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake and FD&C yellow no. 6 aluminum lake;
- 1.25 mg tablets contain iron oxide yellow.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/14/2015
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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